Primiparous Women With Singleton Baby at TermNCT01926314
The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction
A study testing PHENIX Neuromuscular Stimulation Therapy System device and usual home care without device in people with Primiparous Women With Singleton Baby at Term, run by Peking Union Medical College Hospital at 4 sites in China.
Trial summary
Pregnancy and childbirth are considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction. This may leed to devastating loss of function and quality of life.The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training with the device "PHENIX… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primiparous Women With Singleton Baby at Term
- What is being tested?
- PHENIX Neuromuscular Stimulation Therapy System device and usual home care without device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesChina
- Study dates
- Aug 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- primiparous delivery
- term delivery
- single childbirth
- aged from 18-50yrs
Who cannot join
- urinary incontinence before pregnancy
- fecal incontinence before pregnancy
- organ prolapse before pregnancy
- history of childbirth or induced labor with pregnancy more than 28 weeks
- multiparity
- newborn weight less than 2500 grams or more than 4000 grams
Show all 13Show fewer
- precipitate labor
- complication of pregnancy
- asthma
- long-term abdominal pressure(chronic cough>1 month,chronic constipation)
- diabetes
- sciatica
- history of pelvic operation
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Lan Zhu, 86-10-69156238, zhu_julie@sina.com
Lan Zhu
- Recruiting
Foshan maternal and child health hospital
Foshan, Guangdong, 528000
Yuling Wang, 86-13049161630, wujun701121@126.com
Yuling Wang
- Recruiting
The first affiliated hospital of Guangzhou medical college
Guangzhou, Guangdong, 510120
Xiaowei Zhang, 86-13609086710, xwzhang81341235@163.com
xiaowei zhang
- Recruiting
Wuxi Maternal and Child Health Hospital, Nanjing Medical University
Wuxi, Jiangsu, 214002
Jian Gong, gongjianwx@126.com
Jian Gong
About this study
Official title: The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction- a Multiple Centers Cooperation Research.
Pregnancy and childbirth are considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction. This may leed to devastating loss of function and quality of life.The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training with the device "PHENIX Neuromuscular Stimulation Therapy Systems" on the recovery of pelvic floor function for primiparous women.
- Being tested
- PHENIX Neuromuscular Stimulation Therapy System device, usual home care without device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHENIX Neuromuscular Stimulation Therapy System deviceDevice
usual home care without deviceOther
| Study group | Role | What they receive |
|---|---|---|
| device | Experimental | Patients in this group will be offered pelvic floor muscle rehabilitation program using PHENIX Neuromuscular Stimulation Therapy System device. The participants will start therapy once a week 42 days after delivery, and last 8 weeks. Receives: Device: PHENIX Neuromuscular Stimulation Therapy System device |
| usual home care without device | Active comparator | Patients in this group will receive usual home care without device. Receives: Other: usual home care without device |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength of deep muscle fiber I
Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.
Measured: 42 days after delivery
strength of deep muscle fiber I
Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.
Measured: 6 months after delivery
strength of deep muscle fiber I
Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.
Measured: 12 months after delivery
strength of deep muscle fiber II
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
Measured: 42 days after delivery
strength of deep muscle fiber II
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
Measured: 6 months after delivery
strength of deep muscle fiber II
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
Measured: 12 months after delivery
muscular fatigue level
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
Measured: 42 days after delivery
muscular fatigue level
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
Measured: 6 months after delivery
muscular fatigue level
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
Measured: 12 months after delivery
myoelectric potential
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
Measured: 42 days after delivery
myoelectric potential
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
Measured: 6 months after delivery
myoelectric potential
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
Measured: 12 months after delivery
A3 reflex
A3 reflex is one of the index of urinary continence function of pelvic floor.
Measured: 42 days after delivery
A3 reflex
A3 reflex is one of the index of urinary continence function of pelvic floor.
Measured: 6 months after delivery
A3 reflex
A3 reflex is one of the index of urinary continence function of pelvic floor.
Measured: 12 months after delivery
dynamic pressure of pelvic floor
dynamic pressure of pelvic floor is one of the index of urinary continence function.
Measured: 42 days after delivery
dynamic pressure of pelvic floor
dynamic pressure of pelvic floor is one of the index of urinary continence function.
Measured: 6 months after delivery
dynamic pressure of pelvic floor
dynamic pressure of pelvic floor is one of the index of urinary continence function.
Measured: 12 months after delivery
Secondary outcomes (6)
change from baseline in PFIQ-7 scores
Measured: 42 days after delivery
change from baseline in PFIQ-7 scores
Measured: 6 months after delivery
change from baseline in PFIQ-7 scores
Measured: 12 months after delivery
in subjects sexually active at baseline, assessment of sexual function using PISQ-12
Measured: 42 days after delivery
in subjects sexually active at baseline, assessment of sexual function using PISQ-12
Measured: 6 months after delivery
in subjects sexually active at baseline, assessment of sexual function using PISQ-12
Measured: 12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primiparous Women With Singleton Baby at TermStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926314
- Sponsor's protocol ID
- pumch-gyn-06
- Status last verified
- Aug 2013
- First submitted
- 17 Aug 2013
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction- a Multiple Centers Cooperation Research.
- ClinicalTrials.gov ID
- NCT01926314
- Acronym / sponsor ID
- pumch-gyn-06
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnancy and childbirth are considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction. This may leed to devastating loss of function and quality of life.The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training with the device "PHENIX Neuromuscular Stimulation Therapy Systems" on the recovery of pelvic floor function for primiparous women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| device | Experimental | Device: PHENIX Neuromuscular Stimulation Therapy System devicePatients in this group will be offered pelvic floor muscle rehabilitation program using PHENIX Neuromuscular Stimulation Therapy System device. The participants will start therapy once a week 42 days after delivery, and last 8 weeks. |
| usual home care without device | Active comparator | Other: usual home care without devicePatients in this group will receive usual home care without device. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- primiparous delivery
- term delivery
- single childbirth
- aged from 18-50yrs
Key exclusion criteria (13 listed)
- urinary incontinence before pregnancy
- fecal incontinence before pregnancy
- organ prolapse before pregnancy
- history of childbirth or induced labor with pregnancy more than 28 weeks
- multiparity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHENIX Neuromuscular Stimulation Therapy System device | Device | device |
| usual home care without device | Other | usual home care without device |
Primary outcome
strength of deep muscle fiber I
Time frame: 42 days after delivery
Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.
strength of deep muscle fiber I
Time frame: 6 months after delivery
Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.
strength of deep muscle fiber I
Time frame: 12 months after delivery
Strength of deep muscle fiber I is one of the index of electrophysiology function of pelvic floor.
strength of deep muscle fiber II
Time frame: 42 days after delivery
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
strength of deep muscle fiber II
Time frame: 6 months after delivery
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
strength of deep muscle fiber II
Time frame: 12 months after delivery
Strength of deep muscle fiber II is one of the index of electrophysiology function of pelvic floor.
muscular fatigue level
Time frame: 42 days after delivery
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
muscular fatigue level
Time frame: 6 months after delivery
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
muscular fatigue level
Time frame: 12 months after delivery
muscular fatigue level is one of the index of electrophysiology function of pelvic floor.
myoelectric potential
Time frame: 42 days after delivery
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
myoelectric potential
Time frame: 6 months after delivery
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
myoelectric potential
Time frame: 12 months after delivery
myoelectric potential is one of the index of electrophysiology function of pelvic floor.
A3 reflex
Time frame: 42 days after delivery
A3 reflex is one of the index of urinary continence function of pelvic floor.
A3 reflex
Time frame: 6 months after delivery
A3 reflex is one of the index of urinary continence function of pelvic floor.
A3 reflex
Time frame: 12 months after delivery
A3 reflex is one of the index of urinary continence function of pelvic floor.
dynamic pressure of pelvic floor
Time frame: 42 days after delivery
dynamic pressure of pelvic floor is one of the index of urinary continence function.
dynamic pressure of pelvic floor
Time frame: 6 months after delivery
dynamic pressure of pelvic floor is one of the index of urinary continence function.
dynamic pressure of pelvic floor
Time frame: 12 months after delivery
dynamic pressure of pelvic floor is one of the index of urinary continence function.
6 secondary outcomes
change from baseline in PFIQ-7 scores
Time frame: 42 days after delivery
change from baseline in PFIQ-7 scores
Time frame: 6 months after delivery
change from baseline in PFIQ-7 scores
Time frame: 12 months after delivery
in subjects sexually active at baseline, assessment of sexual function using PISQ-12
Time frame: 42 days after delivery
in subjects sexually active at baseline, assessment of sexual function using PISQ-12
Time frame: 6 months after delivery
in subjects sexually active at baseline, assessment of sexual function using PISQ-12
Time frame: 12 months after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan Zhu principal investigator
Peking Union Medical College Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHENIX Neuromuscular Stimulation Therapy System device and usual home care without device in people with Primiparous Women With Singleton Baby at Term, run by Peking Union Medical College Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lan Zhu (86-10-69156238, zhu_julie@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
strength of deep muscle fiber I (time frame: 42 days after delivery). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2013.